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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON
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PHILIPS MEDICAL SYSTEMS ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON Back to Search Results
Model Number M2736A
Device Problem Device Alarm System (1012)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that there was an alarm failure.Additional details are unknown at this time.The device was used for patient monitoring at the time of the alleged malfunction.
 
Manufacturer Narrative
H10:the reported issue was investigated by remote support and it was determined that the ultrasound transducer needed to be replaced.Av-us ultrasound xdr (b)(4) was sent to customer to resolve the issue.Several attempts were made to gather additional information, but none were provided.Additionally, no further contact was established by the customer regarding the reported device and issue.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON
Type of Device
ULTRASOUND TRANSDUCER
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key11290275
MDR Text Key231654043
Report Number9610816-2021-00039
Device Sequence Number1
Product Code HGM
UDI-Device Identifier00884838002722
UDI-Public(01)00884838002722
Combination Product (y/n)N
PMA/PMN Number
K062137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM2736A
Device Catalogue Number989803143691
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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